Impact of Mild or Moderate Physical Activity and Progression of Subclinical Atherosclerosis (MoMA)
Primary Purpose
Atherosclerosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Moderate to vigorous physical activity
Light physical activity
Sponsored by
About this trial
This is an interventional prevention trial for Atherosclerosis
Eligibility Criteria
Inclusion Criteria:
- Inactivity during leisure time as assessed through the long version of the International Physical Activity Questionnaire;
- Apparent health defined as 1) no known CVD (coronary, cerebrovascular or peripheral vascular disease), and 2) no known cardiovascular risk factors or cardiovascular medications (hypertension, dyslipidemia, diabetes, active smoking within past year, or clinical obesity defined as body mass index (BMI) ≥ 30kg/m2);
- Signed consent form.
Exclusion Criteria:
- Known dyslipidemia (participants receiving lipid-lowering medication, or in the absence of such medication, having: a fasting total plasma cholesterol level > 6.2 mmol/L, a triglyceride level ≥ 1.7 mmol/L, and/or HDL-cholesterol level < 1.0 mmol/L in men and < 1.3 mmol/L in women);
- Hypertension (participants receiving antihypertensive medications or having blood pressure ≥ 135/85 mmHg);
- Diabetes (participants taking diabetes medication or having plasma HbA1c ≥ 6.5%);
- Postmenopausal women;
- Pregnancy or nursing in the past year or expected in the next two years;
- Contraindications to MRI, as per the standardized IUCPQ MRI screening form;
- Participation in another research study.
Sites / Locations
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control
Moderate to vigorous physical activity
Light physical activity
Arm Description
Continued inactivity
MVPA (55-90% of maximum heart rate) for 150 min/week (current recommendations)
LPA (40-55% of maximum heart rate) for 150 min/week
Outcomes
Primary Outcome Measures
Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI)
Secondary Outcome Measures
Change in waist circumference
Change in hip circumference
Change in BMI
Change in abdominal visceral adipose tissue
Change in abdominal subcutaneous adipose tissue
Change in thoracic visceral adipose tissue
Change in hepatic fat fraction
Change in blood pressure
Change in standard plasma lipid fractions
Change in plasma apolipoprotein A1
Change in plasma apolipoprotein B
Change in plasma lipid particle size
Change in blood glucose
Change in blood insulin
Change in blood HbA1c
Change in adiponectin
Change in IL-6
Change in TNF-alpha
Change in CRP
Full Information
NCT ID
NCT02628275
First Posted
November 26, 2015
Last Updated
October 2, 2023
Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT02628275
Brief Title
Impact of Mild or Moderate Physical Activity and Progression of Subclinical Atherosclerosis
Acronym
MoMA
Official Title
Will Mild vs. Moderate Physical Activity Suffice to Abate the Progression of Subclinical Atherosclerosis in Sedentary Adults?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
October 2022 (Actual)
Study Completion Date
October 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Subclinical atherosclerosis is identified in roughly 2/3rd of otherwise healthy young adults. How much physical activity is required to prevent progression of subclinical atherosclerosis? In the 85% of healthy younger Canadian men and women who do NOT perform the recommended 150 min/week of moderate- to vigorous-intensity physical activity (MVPA) as recommended, is it reasonable to aim for a lower regimen of light physical activity (LPA) despite the absence of supporting literature, or to the contrary should the investigators insist on achieving MVPA? In this perspective, MoMA provides a unique opportunity to determine whether LPA vs. MVPA is necessary to limit subclinical atherosclerosis progression in inactive otherwise healthy adults. Resolving such unknowns should inform strategies to prevent decades of silent disease progression leading to future morbidity and mortality.
Detailed Description
Cardiovascular disease (CVD) remains rampant in developed regions, topping the list of causes of mortality leading to 29% of all deaths. In addition to mortality, the economic impact of morbidity and hospitalization related to CVD costs Canadians over $22.2 billion every year. By far the leading cause of CVD is atherosclerosis defined as a thickening of the arterial wall with fatty deposits. Therefore, atherosclerosis is the underlying mechanism behind the #1 cause of mortality and morbidity in developed regions. Autopsy studies performed in healthy casualties of the Korean, Vietnam, Iraq and Afghanistan Wars revealed that atherosclerosis is present in up to 78% of young men before their 30th birthday, even in the absence of traditional risk factors (high blood pressure, dyslipidemia, obesity). Prevention of atherosclerosis and its silent progression towards clinical events decades later should therefore become a priority in all young adults. A potentially powerful avenue of cardiovascular prevention lies in the reduction of subclinical atherosclerosis progression in younger adults through physical activity. Unfortunately, only 15% of Canadians meet the current recommendations for 150min/week of moderate- to vigorous-intensity physical activity (MVPA). In response to the observation that Canadians simply don't find time for/or do not appear to value current recommendations, it was suggested that even light-intensity physical activity (LPA) might improve biomarker levels compared to a sedentary lifestyle. It appears that in the face of failed attempts to convince Canadians to perform 150min/week of MVPA, expectations towards LPA have been lowered despite the absence of convincing data.
MoMA is a randomized controlled trial to study the effects of two doses of physical activity on subclinical atherosclerosis burden progression; 270 inactive men and women aged 18-40 years without CVD or risk factors will be enrolled. At baseline, risk factors, physical activity level and nutritional habits will be measured through validated questionnaires; blood work and anthropometric parameters measurements will be performed (markers of cardiometabolic risk); fitness level will be assessed through treadmill test and accelerometer; magnetic resonance imaging of carotid atherosclerosis, liver and adipose tissue will be performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Continued inactivity
Arm Title
Moderate to vigorous physical activity
Arm Type
Active Comparator
Arm Description
MVPA (55-90% of maximum heart rate) for 150 min/week (current recommendations)
Arm Title
Light physical activity
Arm Type
Active Comparator
Arm Description
LPA (40-55% of maximum heart rate) for 150 min/week
Intervention Type
Behavioral
Intervention Name(s)
Moderate to vigorous physical activity
Intervention Description
55-90% maximum heart rate for 150min/week (current recommendations)
Intervention Type
Behavioral
Intervention Name(s)
Light physical activity
Intervention Description
40-55% maximum heart rate for 150min/week
Primary Outcome Measure Information:
Title
Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI)
Time Frame
Baseline, 1 year, 2 years
Secondary Outcome Measure Information:
Title
Change in waist circumference
Time Frame
Baseline, 1 year, 2 years
Title
Change in hip circumference
Time Frame
Baseline, 1 year, 2 years
Title
Change in BMI
Time Frame
Baseline, 1 year, 2 years
Title
Change in abdominal visceral adipose tissue
Time Frame
Baseline, 1 year, 2 years
Title
Change in abdominal subcutaneous adipose tissue
Time Frame
Baseline, 1 year, 2 years
Title
Change in thoracic visceral adipose tissue
Time Frame
Baseline, 1 year, 2 years
Title
Change in hepatic fat fraction
Time Frame
Baseline, 1 year, 2 years
Title
Change in blood pressure
Time Frame
Baseline, 1 year, 2 years
Title
Change in standard plasma lipid fractions
Time Frame
Baseline, 1 year, 2 years
Title
Change in plasma apolipoprotein A1
Time Frame
Baseline, 1 year, 2 years
Title
Change in plasma apolipoprotein B
Time Frame
Baseline, 1 year, 2 years
Title
Change in plasma lipid particle size
Time Frame
Baseline, 1 year, 2 years
Title
Change in blood glucose
Time Frame
Baseline, 1 year, 2 years
Title
Change in blood insulin
Time Frame
Baseline, 1 year, 2 years
Title
Change in blood HbA1c
Time Frame
Baseline, 1 year, 2 years
Title
Change in adiponectin
Time Frame
Baseline, 1 year, 2 years
Title
Change in IL-6
Time Frame
Baseline, 1 year, 2 years
Title
Change in TNF-alpha
Time Frame
Baseline, 1 year, 2 years
Title
Change in CRP
Time Frame
Baseline, 1 year, 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Inactivity during leisure time as assessed through the long version of the International Physical Activity Questionnaire;
Apparent health defined as 1) no known CVD (coronary, cerebrovascular or peripheral vascular disease), and 2) no known cardiovascular risk factors or cardiovascular medications (hypertension, dyslipidemia, diabetes, active smoking within past year, or clinical obesity defined as body mass index (BMI) ≥ 30kg/m2);
Signed consent form.
Exclusion Criteria:
Known dyslipidemia (participants receiving lipid-lowering medication, or in the absence of such medication, having: a fasting total plasma cholesterol level > 6.2 mmol/L, a triglyceride level ≥ 1.7 mmol/L, and/or HDL-cholesterol level < 1.0 mmol/L in men and < 1.3 mmol/L in women);
Hypertension (participants receiving antihypertensive medications or having blood pressure ≥ 135/85 mmHg);
Diabetes (participants taking diabetes medication or having plasma HbA1c ≥ 6.5%);
Postmenopausal women;
Pregnancy or nursing in the past year or expected in the next two years;
Contraindications to MRI, as per the standardized IUCPQ MRI screening form;
Participation in another research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Larose, DVM, MD
Organizational Affiliation
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
City
Québec
ZIP/Postal Code
G1V 4G5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Impact of Mild or Moderate Physical Activity and Progression of Subclinical Atherosclerosis
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